MEDTRONIC, INC. · CRT-Pacemaker (CRT-P) · First cleared Mar 2011
Total Reports
202
Reports (30d)
2
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Lead Set Screw Failure During Implant
generator, implantable pulse, lead, pulse generator, ipg
3
reports
Infection Leading to Device Explantation
infection, event patient, patient complications, complications, result event
2
reports
Premature Battery Depletion and Replacement
use, crt exhibited, explanted replaced, premature battery, battery depletion
2
reports
Template Summary: Device Field Analysis
received indicating, analyzed, noise, observed, field
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Apr 6, 2021 · Open, Classified
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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